The Kinesio-taping for the Prevention of Painful Shoulder and for the Functional Recovery of Upper Limb After Stroke

NCT05156164 | Completed DMC

• 1 other identifier: Prot. CE/PROG.937 FSL
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This RCT aims to investigate the effectiveness of the early use of Kinesio-taping (KT) together with standard physiotherapy treatment, in the prevention of the shoulder pain of the hemiplegic upper limb following a cerebral stroke compared to conventional physiotherapy without KT treatment. As a secondary outcome, this RCT aims to investigate if KT could improve functional recovery and delay the onset of spasticity. The study consists in two parallel groups of 15 participants each. The treatment and observation period will last 1 month.

Conditions

Stroke, Rehabilitation

Keywords

Kinesio tape; Pain; Preventative Care; Spasticity; Muscle; Stroke; Rehabilitation; Functional Performance

Outcome Measures

Primary Outcomes (1)

• To assess the change of Ritchie Articular Index

  The Ritchie Articular Index (RAI) is an 4 point index for the numerical measurement of joint tenderness. It grades 0: no tenderness, 1: patient complained of pain, 2: patient complained of pain and winced, 3: patient complained of pain and winced and withdrew. 0 is the better outcome, 3 is the worse outcome. The shoulder joint pain will be assessed

  Initial assessment: after enrollment. Intermediate evaluation after 3 weeks, before the fifth treatment. Final evaluation after 5 weeks since enrollment

Secondary Outcomes (2)

• To assess the change of FUGL-MEYER ASSESSMENT UPPER EXTREMITY

  Initial assessment: after enrollment. Intermediate evaluation after 3 weeks, before the fifth treatment. Final evaluation after 5 weeks since enrollment

• To assess the change of Modified Ashwort Scale

  Initial assessment: after enrollment. Intermediate evaluation after 3 weeks, before the fifth treatment. Final evaluation after 5 weeks since enrollment

Study Arms (2)

Kinesio-taping Group

EXPERIMENTAL

Conventional rehabilitative treatment (consisting in two treatments per day of 40 minutes each) plus a bi-weekly treatment focused on the joint complex of the shoulder plus Kinesio-taping (KT) treatment. The Kinesio-taping treatment consists in 4 applications of KT on the affected shoulder to be held for 5 days a week, followed by 2 days of rest to safeguard skin integrity before a further application. 5 KT strips with graded tensions will be placed on the following muscles: 1. supraspinatus with a tension of 70%. 2. infraspinatus with a tension of 70%. 3,4,5) deltoid (3 strips, 50% of tension) A sixth application with a tension of 90% originates at the level of the anterior face of the humeral head and it ends to the lower corner of the scapula.

Device: Kinesio Tape Group

Control Group

SHAM COMPARATOR

Conventional rehabilitative treatment (consisting in two treatments per day of 40 minutes each), plus a bi-weekly treatment focused on the joint complex of the shoulder, plus shame KT treatment. \- The CG will undergo a KT application on the deltoid but without support function with the same frequency and duration as the experimental group (shame-application).

Device: Control Group

Interventions

Kinesio Tape Group DEVICE

The application of the KT consists of 6 strips of I-shaped tape adhered to the skin areas of the shoulder

Kinesio-taping Group

Control Group DEVICE

KT application on the deltoid but without support function

Control Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a first episode of ischemic or hemorrhagic stroke.
• Hypotonia of the stabilizing muscles of the shoulder.
• Enrollment within 1 month of stroke.

You may not qualify if:

• Previous trauma or chronic tendinopathies of the shoulder musculature.
• Skin problems such as wounds or hypersensitivity.
• Severe psychiatric or cognitive deficits.
• Anesthesia of the hemiplegic side.
• Severe aphasia
• Severe neglect

Sponsors & Collaborators

• I.R.C.C.S. Fondazione Santa Lucia: lead

Study Sites (1)

I.R.C.C.S. Fondazione Santa Lucia

Roma, RM, 00179, Italy

Location

Related Publications (4)

• Huang YC, Leong CP, Wang L, Wang LY, Yang YC, Chuang CY, Hsin YJ. Effect of kinesiology taping on hemiplegic shoulder pain and functional outcomes in subacute stroke patients: a randomized controlled study. Eur J Phys Rehabil Med. 2016 Dec;52(6):774-781. Epub 2016 Aug 30.

  PMID: 27575012 BACKGROUND

• Van Langenberghe HV, Hogan BM. Degree of pain and grade of subluxation in the painful hemiplegic shoulder. Scand J Rehabil Med. 1988;20(4):161-6.

  PMID: 3232046 BACKGROUND

• Ravichandran H, Janakiraman B, Sundaram S, Fisseha B, Gebreyesus T, Yitayeh Gelaw A. Systematic Review on Effectiveness of shoulder taping in Hemiplegia. J Stroke Cerebrovasc Dis. 2019 Jun;28(6):1463-1473. doi: 10.1016/j.jstrokecerebrovasdis.2019.03.021. Epub 2019 Apr 5.

  PMID: 30956057 BACKGROUND

• Griffin A, Bernhardt J. Strapping the hemiplegic shoulder prevents development of pain during rehabilitation: a randomized controlled trial. Clin Rehabil. 2006 Apr;20(4):287-95. doi: 10.1191/0269215505cr941oa.

  PMID: 16719027 BACKGROUND

MeSH Terms

Conditions

Stroke; Pain; Muscle Spasticity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Stefano Brunelli, MD

  I.R.C.C.S. Fondazione Santa Lucia, Roma, Italy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Randomized Parallel Assignment

Study Record Dates

• First Submitted: November 14, 2021
• First Posted: December 14, 2021
• Study Start: January 1, 2022
• Primary Completion: October 1, 2022
• Study Completion: March 1, 2023
• Last Updated: June 7, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: Beginning 3 months and ending 5 years following article publication
• Access Criteria: Proposals should be directed to the personal corrisponding author's mail address.

Locations

IT (1)